RU2752298C1 - Biologically active dietary supplement for normalising lipid metabolism and method for application thereof - Google Patents

Abstract

FIELD: foodstuffs.SUBSTANCE: inventions relate to the food industry and can be used in producing biologically active food supplements, including polyunsaturated fatty acids (PUFAs) of the omega-3 family, phospholipids and antioxidants, for normalising lipid metabolism. The claimed biologically active dietary supplement comprises fat of the Japanese sardine and natural antioxidant betulin obtained from birch bark extract, at the following weight ratio of ingredients: 100:0.02 to 0.10.EFFECT: invention allows expanding the range of biologically active dietary supplements with a high content of sea PUFAs of the omega-3 family and phospholipids, increasing the shelf life thereof allowing including it in the diet for patients with lipid metabolism disorders and at-risk persons for a long time without changing the quality of the biologically active dietary supplement.2 cl, 2 tbl, 5 ex

Description

The inventions relate to the food and pharmaceutical industries and can be used in the production of biologically active additives (BAA) to food, including polyunsaturated fatty acids (PUFA) of the omega-3 family, phospholipids and antioxidants.

PUFAs of the omega-3 family are capable of exerting a pronounced therapeutic and prophylactic effect on the human body, the most significant among them are eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids. PUFAs of the omega-3 family are recommended for direct consumption as part of a diet in a complex of therapeutic measures in the treatment of various diseases associated with lipid metabolism disorders (dyslipidemias), which is the most important risk factor for the development and progression of coronary heart disease, atherosclerosis, angina pectoris, hypertension heart, diabetes, liver disease and other serious ailments. For example, polyunsaturated fatty acids of the omega-3 family have a hypolipidemic effect; in the treatment of chronic ischemic heart disease at a dose of 4-6 g, they are a second-line agent for correcting hypertriglyceridemia (Clinical guidelines "Diagnosis and treatment of chronic ischemic heart disease" on urgent cardiology and the profile commission on cardiology. 2013. 69 p). Phospholipids ensure the functioning of cell membranes, regulate cholesterol metabolism, prevent the development of liver diseases and fatty degeneration (Kunz et al. Therapeutic archive. 1994. No. 2. P. 66-72). The use of antioxidants in the production of dietary supplements of lipid origin makes it possible to enhance the pronounced positive effect of additives on the human body and maintain the original quality of the product.

It is known that a rich source of valuable lipids - PUFAs of the omega-3 family and phospholipids is fat obtained from fish and its production waste, from marine mammals and non-fish objects (Boeva et al. "Technology of fats from aquatic biological resources." - M .: Publishing house VNIRO, 2016.107 p.). On the basis of fish fats, a number of dietary supplements have been created for food, recommended for use as drugs with a therapeutic and prophylactic effect (Vaskovsky et al. "Preparations of omega-3 fatty acids and their use in medicine" // Pacific Medical Journal. 2010. No. 2 . S. 16-20). Since a feature of fish oil is low storage capacity due to the high activity of oxidative and hydrolytic processes, which necessitates the use of antioxidants and stabilizers in the technology of dietary supplements based on fish oils.

Known biological food additive (BAA), consisting of fish oil obtained from frozen liver of cod or cod fish, containing at least 15.0% PUFA. The shelf life of the liquid product is 6 months, in capsules - 24 months from the date of manufacture, subject to storage conditions: protected from light in a dry place at a temperature not exceeding 18 ° C (RF Patent No. 2363726, IPC S11B 3/100, publ. 10.08 .2009, bulletin 22).

The disadvantages of this dietary supplement include:

- low content of polyunsaturated fatty acids - 15%, although the authors even use the stage of winterization (freezing of saturated triglycerides) to increase it, however, as you can see, there is no effect;

- initially, it is irrational to use frozen liver, since at a storage temperature of minus 18 ° C, active hydrolytic and oxidative processes occur in the liver (lipase and phospholipysis enzymes exhibit high activity), which leads to a decrease in the content of PUFA directly in the raw material from which the dietary supplement is produced;

- the additive obtained by this method is devoid of phospholipids, since they are irretrievably sorbed on activated clay and coal during refining and deodorization, besides, the last stage of fat purification from organochlorine pesticides - molecular distillation - puts an end to their content;

- the shelf life of dietary supplements both in bulk and in encapsulated forms is low - 6 and 12 months, respectively, which is at least 2 times lower than that of other manufacturers;

- the process of obtaining dietary supplements is very delayed, multi-stage, which obviously will affect the cost of the final product, and given the low content of PUFA, the consumer will have a choice based on the price / efficiency ratio.

Known biologically active food additive "Pentamarin" (Patent No. 2446713, IPC A23L 1/30, A23L 1/0532, A23D 7/00, publ. 10.04.2012, bull. No. 10), which includes a fat module - fat of marine mammals with the content of PUFAs of the omega-3 family at least 20 wt%, and a carbohydrate module, which includes, wt%: fructose - (10-12), sodium alginate - (0.7-1.5) and water - rest. The dietary supplement has a shelf life of 24 months. Fat and carbohydrate modules are placed in separate chambers, with the ratio (1-3.33): (23.33-25.67). Mixing of fat and carbohydrate modules is carried out immediately before use.

The disadvantages of the present invention include

- low content of PUFA - 20%; the authors should clarify what species of marine mammals they use to obtain dietary supplements;

- the description does not contain data on the quality characteristics of the fat module (fat) and its change during the storage period; a long shelf life of marine mammals' fat without the introduction of antioxidants naturally leads to hydrolytic and oxidative processes, the accumulation of lipid oxidation products in the fat and a decrease in PUFA in it, in particular, of the omega-3 family; for the final product there are no indicators of oxidative deterioration - acid and peroxide numbers;

- in the examples, the authors indicate that fat for dietary supplements can be taken in accordance with GOST 1304-76 "Technical fats of fish and marine mammals", while the quality of such fat is far from food standards;

- fat from marine mammals with a good culture of production is rendered only from khorovina (subcutaneous fat), therefore there are no phospholipids in it;

- 1 bottle of a ready-made dietary supplement contains only 0.9 ml of fat, therefore, to meet an adequate daily dose of omega-3 series PUFAs, the consumer needs to take 5 bottles or 120 ml of the total mixture, while due to the fructose content for many categories of patients it will be unacceptable;

- the authors give a shelf life at 0-20 ° C - at least 36 months, without the use of antioxidants in fat and in an aqueous solution, it cannot be guaranteed.

Known dietary supplement based on fish oil "Eikonol" (RF Patent No. 2427616, IPC S11B 1/00, publ. 27.08.2011, bull. No. 24), in the production of which pelagic fish species are used as raw materials. The method includes grinding raw materials, destroying tissue, centrifuging, separating, cooling and keeping the fats until the saturated fraction of fat crystallizes completely and separating the unsaturated fraction. After grinding, food acid is added to the raw material at a ratio of acid to fish of 0.5-1.0: 100 and a temperature of 15 to 40 ° C to extract fat. Before cooling, the fats are refined to remove free fatty acids, and the fat is cooled to a temperature of 0 ° C for 5-20 hours, the unsaturated fat fraction is separated by vacuum filtration, and the final product is stabilized with tocopherol, krill fat or the antioxidant LATL in an amount of 0.5 -1.0 wt%. The content of the total amount of PUFA in Eikonol fat is 38%, and the ratio of PUFA omega-6 / omega-3 is 7: 1. The composition of the preparation "Eikonol", in addition to fish oil, includes flaxseed oil in an amount of 20.0%, a stabilizer or antioxidant - 0.5-1.0%.

The disadvantage of the obtained dietary supplement is:

- According to the description, it is permissible to receive dietary supplements from any types of marine fish and waste from their processing; with this approach, it is impossible to normalize the content of marine long-chain acids, primarily EPA and DHA; with such a "spread" of raw materials, problems may arise with the content of toxic elements and organochlorine pesticides;

- low content of PUFAs of the omega-3 family; the predominant group of PUFAs of the omega-6 family is 33.0% of the total amount of fatty acids, or 313.5 mg / g of fat (assuming that PUFAs are contained in an amount of 38%, and the ratio of PUFAs omega-6 / omega -3 is 7: 1); the content of fatty acids of the omega-3 family in Eikonol is no more than 4.75% of the total of all fatty acids, or no more than 44.7 mg / g of fat;

- the authors are trying to increase the content of omega-3 acids in dietary supplements by adding flaxseed oil, which contains 50-55% linolenic acid (omega-3 family, 18 carbon atoms, 3 double bonds) and due to this they speak of a high content of omega-PUFAs 3, forgetting that the biological activity of EPA and DHA cannot be compared with linolenic acid, which in the body has yet to be metabolized to these acids, and the coefficient of such conversion is only about 0.5%;

- the preparation is devoid of marine phospholipids, since the use of phosphoric acid is permissible in the technology, and one of the purification stages involves filtration through silica gel;

- The dietary supplement is offered to a wide range of consumers to improve metabolism, memory, etc., but given the composition of the dietary supplement, it should not be considered as a valuable source of marine omega-3 acids;

- shelf life of dietary supplements "Eikonol" is not given.

A known method of obtaining fish oil "Eyfitol", used as a dietary supplement (RF Patent No. 2456336, IPC C11B 1/10, publ. 20.07.2012, bull. No. 20). The composition of the drug "Eifitol" includes,%: edible oil based on fish oil "Eikonol" - 90.0-91.0%, garlic extract - 6.3-6.7%, red palm oil - 1.0%, antioxidant LATL (a complex of lecithin, ascorbic and citric acids, alpha-tocopherol-acetate) - 1.3-1.4% and sodium selenite - 0.001%. The shelf life of the product in the form of soft gelatin capsules is 3 years.

The disadvantage of the invention is:

- low content of PUFAs of the omega-3 family (25%), since the main component of Eifitol dietary supplement is Eikonol dietary supplement (not less than 98.0%) (Eikonol dietary supplement, as indicated in the above materials, contains no more 4.75% of the sum of all fatty acids, or - not more than 44.7 mg / g of fat;

- the main active ingredient of garlic is allicin, in certain cases dermatitis or allergic reactions may develop, in addition, this component can provoke internal bleeding if taken simultaneously with the use of blood thinners (omega-3 acids are just this remedy) - it will enhance their effect, which will cause possible hemorrhages;

since the extract enhances the production of insulin, it is not recommended to take it simultaneously with drugs that reduce sugar, etc.

- the drug is completely devoid of marine phospholipids;

- the authors argue that it has an anti-sclerotic effect, normalizes the content of blood lipids, etc., but what its real effectiveness is not given;

- the shelf life of dietary supplements -36 months. and this is not surprising, since weakly oxidized plant PUFAs (linoleic and linolenic acids) are present in the composition, and antioxidants are added in significant quantities.

A dietary supplement is known that can be used in diet therapy for the prevention of cardiovascular diseases, as well as a wide variety of diseases associated with metabolic disorders, etc. (RF patent No. 2555456, IPC А23L 1/30, А23L 1/325, publ. 10.07.2015, bul. No. 19). The additive is a multicomponent product including fish oil (60-80%), refractory vegetable oil (15-35%), beeswax (3-15%), sweetener (5-15%), flavorings (0.1- 2.0%), flavoring (0.05-0.2%), antioxidants.

This dietary supplement and its possible use have disadvantages:

- the authors do not mention in the description what (what) fish oils they are talking about - whether these fats are oceanic or obtained from freshwater fish is not clear; on the one hand, prevention of cardiovascular diseases, on the other hand, a complete lack of information about fat and the content of useful omega-3 PUFAs in it;

- The dietary supplement includes significant amounts of additional components that are little associated with cardiovascular diseases, for example, saturated fats are contraindicated in such diseases, and carbohydrates (sugar and fructose) sharply limit the intake of supplements by various groups of the population;

- since the composition of fish oil is not standardized by the authors, it can be assumed that it will be any fish oil from the market, even with a very low nutritional value.

- the use of such a drug will not improve the patient's well-being, but can only provoke additional difficulties with health.

Known therapeutic and prophylactic fat from fish liver for use in cardiovascular diseases (RF Patent No. 2224529, IPC A61K 35/60, A61P 3/02, publ. 27.04.2004).

This drug (dietary supplement) has the following disadvantages:

- the authors, according to the description, use the liver of marine fish, but in the example only the liver of pollock; unfortunately, this is one of the poorest sources of omega-3 PUFAs - usually no more than 20% of the total fatty acids.

- since the source is the liver of the fish, then, accordingly, you need to pay great attention to the content of vitamin A, it is very significant in the liver and fat from it, depending on the fishing season; it is very easy to overdose on vitamin A from taking such fat.

- due to the low content of omega-3 PUFAs, this fat should be considered rather as a source of vitamins A and D, but not omega-3 fatty acids.

The closest to the claimed dietary supplement is a functional food ingredient (BAA) for the normalization of lipid metabolism (RF Patent No. 2524358, IPC A23L 1/29, A23L 1/325, A23L 1/303, publ. 07/27/2014, bull. No. 21), containing fish oil of aquaculture African catfish Clarias Gariepinus and natural antioxidant alpha-tocopherol (0.02-0.05% by weight of fish oil). Fish oil contains at least 25% polyunsaturated fatty acids, while the sum of EPA and DHA is at least 5% (237.5 mg / g of the ingredient, and the sum of EPA and DHA is 5% or 47.5 mg / g of the ingredient).

The disadvantages of a functional food ingredient with a given lipid profile are:

- PUFAs account for 25% of the total amount of fatty acids or 237.5 mg / g of the ingredient, and the amount of EPA and DHA is 5% or 47.5 mg / g; with daily consumption according to the standards of the Federal Research Center "Nutrition and Biotechnology" for dietary supplements to be at least 20 g, which is unacceptable for an ordinary consumer;

- no data is provided on the content of antibiotics and other toxic substances in fat, although it is known that mass-cultivated fish cannot avoid such contamination;

- fat does not contain phospholipids;

- data on fat storage are not known.

The closest in pharmacological properties of impact on the body is a functional food product (FPP), which has cardioprotective and other properties (RF Patent No. 2602608, IPC A23L 33/105, A23L 17/00, publ. 20.11.2016, bull. No. 32 ). The product is a mixture of herbal oil and salmon oil, where the oil extract content can be up to 50%. For the prevention and treatment of cardiovascular diseases. PPP will exhibit functional properties and biological activity when contained in the product:

- oil extract of lemongrass fruit (1:30) in the amount of 16.7-21.3%;

- oil extract of motherwort herb (1:10) in the amount of 3.6-23%;

- oil extract of chamomile flowers (1:10) in the amount of 17.8-46%.

In accordance with MP 2.3.1.2432-08, the maximum physiological need for an adult per day is: PUFA - 10 g, vitamin A - 3000 ME, vitamin E - 15 mg, vitamin D - 200 ME.

Taking into account the indicators of the content of PUFA, vitamin E and D, an adequate daily intake of PPP is 10 g.

In accordance with MP 2.3.1.1915-04, the content of Schisandra chinensis in food and dietary supplements is standardized for the content of biologically active substances such as schizandrin. The recommended daily intake of schizandrin for adults as part of dietary (therapeutic and prophylactic) food and dietary supplements is 0.5-1 mg.

In accordance with MP 2.3.1.1915-04, the content of motherwort herb in food products and dietary supplements to food is standardized by the content of biologically active substances such as flavonols and their glycosides (quercetin, kaempferol, mericetin, isorhamnetin, rutin).

Chamomile flowers are standardized in accordance with MP 2.3.1.1915-04 for the content of the following substances in products: flavones (luteolin, apigenin, acacetin, diosmetin, baicalin) or flavonoglycosides (vitexin, isovitexin, orientin, isoorientin) and hydroxycinnamic acids (chicoric, rosemary n-coumaric, caftar, chlorogenic, ferulic, coffee).

A functional product has disadvantages:

- the presence of plant extracts in the product creates a positive decision for the sale of the drug, but does not at all affect the possibilities of its consumption by healthy and sick people, for example, lemongrass extracts greatly increase blood pressure - will this be a positive moment for cardiovascular patients?

- according to the patent, salmon fish oil can actually be diluted 2 times with vegetable oil (extract); such a combination gives the functional product an excessive content of vegetable oil - an energy ballast that does not affect the course of the disease, but only adds calories;

- the content of omega-3 PUFAs in the fat of salmon (Far Eastern salmon) is no more than 30% of all fatty acids, therefore, diluting the fat by another 2 times reduces it to 15% - this is even less than in the fat of pollock.

- this functional product can be considered for its intended purpose, but in no way act as a means of prevention and treatment of cardiovascular diseases;

- the use of FPP for prevention and treatment is greatly complicated by the selection of a specific composition individually for each patient, in addition, there is no recommendation to use it to normalize lipid metabolism in patients with this disorder.

A known method for normalizing lipid metabolism (RF Patent No. 2530769, IPC A61K 31/375, A61K 31/352, A61K 31/40, A61K 31/455, A61P 3/06, A61P 9/10, A23L 1/30, publ. 10.10 .2014, bul. No. 28), which consists in the step-by-step administration of quercitin with vitamin support to the patient, then a statin. The tool provides a reduction in blood cholesterol levels, thereby reducing the risk of cardiovascular disease.

However, this method of treatment has disadvantages:

- statins, as substances that specifically inhibit the activity of 3-hydroxy-3-methylglutaryl CoA reductase, an enzyme necessary for one of the first stages of cholesterol synthesis, 1) reduce the level of C-reactive protein (a protein found in the blood that serves as an ideal indicator of inflammation ), and, 2) reduce blood viscosity, facilitating its flow; by suppressing the production of cholesterol in the body in a critical way, they alter most of the normal metabolic processes;

- they have countless unpleasant, and in some cases acute - and even fatal - side effects such as muscle pain, weakness, fatigue, memory and cognition problems, very serious problems with sexual activity (Liu J, Li A, Seneff S. “Automatic Drug Side Effect Discovery from Online Patient-Submitted Reviews: Focus on Statin Drugs.” IMMM 2011, The First International Conference on Advances in Information Mining and Management; October 23, 2011 to October 29, 2011; Barcelona, Spain. 2011);

- despite the fact that statins greatly reduce the level of cholesterol in the blood, their intake has practically no effect on the formation of cholesterol plaques in the vessels - their growth is observed during the entire intake (HS Hecht and SM Harman “Relation of Aggressiveness of Lipid-Lowering Treatment to Changes in Calcified Plaque Burden by Electron Beam Tomography, "American Journal of Cardiology 2003. 92 (3), P. 334-336);

- statins are powerful drugs and should probably be used in the most extreme cases.

A technical problem posed during the creation of inventions is the expansion of the range of dietary supplements to food with a high content of marine PUFAs of the omega-3 family and phospholipids, increasing its shelf life, which allows for a long time, without changing the quality of dietary supplements, to use it in the diet for patients with lipid disorders. exchange and persons at risk.

The claimed technical problem is solved by the fact that in the known biologically active food supplement for normalizing lipid metabolism, containing fish oil and a natural antioxidant, according to the invention, it includes sardine ivashi fat as fish oil, and as a natural antioxidant the food ingredient betulin obtained from extract of birch bark, with the following mass ratio of ingredients: 100: 0.02-0.10.

The use of Sardinops melanostictus sardine ivasi fat in the dietary supplement can significantly increase the content of PUFAs of the omega-3 family and phospholipids, which are actively involved in lipid metabolism. Iwasi sardine, inhabiting the waters of the Far Eastern seas, is characterized by a high fat content, depending on the size composition, its mass fraction in the muscle tissue of fish ranges from 12.2% to 30.0%. The content of phospholipids in the muscle tissue of Iwashi sardine is 5.2-17.1% of the total lipids, PUFA - up to 35.0-40.0% of the total fatty acids. Among them, the dominant group are PUFAs of the omega-3 family, which make up 22.0-35.0% of the total amount of fatty acids, including the total amount of eicosapentaenoic and docosahexaenoic - at least 18.0% (Shulgina LV et al. “Lipid and fatty-acid compositions of muscle tissue from Sardinops melanostictus "// Springer Science + Business Media, Chemistry of Natural Compounds, 2020. Vol. 56, No. 2, P.305-308).

The content of phospholipids in the muscle tissue of Iwashi sardine is 5.2-17.1% of the total lipids, depending on the fishing season.

Phospholipids are important components of cell membranes, which determine their mobility, transport of biological components, affecting the protective properties of the cell, etc. The phospholipid complex plays a special role in the nervous tissue and, first of all, in the brain. Phospholipids, in terms of their physical properties, are excellent natural emulsifiers, which is why they are so often used in cosmetics and the food industry. When consumed, by emulsifying food components, along with cholic acids, they help the penetration of nutrients through the wall of the small intestine. Medicine considers phospholipids, mainly, as effective hepatoprotective agents that help restore liver function in various diseases, including lipid metabolism disorders (M.D. Mashkovsky "Medicines", Moscow: "New Wave", 2012, 16th ed. , Pp. 521-524).

The use in the dietary supplement as a natural antioxidant of the food ingredient betulin, obtained from birch bark extract, ensures the stability of the fat from Iwashi sardine during storage. The food ingredient betulin is an isolate from an extract of birch bark, in which the main (at least 98.0%) substance is pentacyclic triterpene alcohol (betulin) (Food supplement “Betulin” produced by LLC “Cortex”, Tyumen). Other betulins can also be used, in particular, BetulaPharm LLC, offers a highly purified Betulin preparation (99.9%), Drevit LLC also offers a highly purified Betulin preparation (99.9%), Sigma Betulin -Aldrich "(USA), product purity - 98.0%, LLC" Inkoda ", Tyumen, product purity - 98.8%, you can get almost pure betulin yourself according to RF patent No. 2074867.

Betulin is insoluble in water, forms a suspension with oils and fats. The recommended level of consumption of betulin per day for a person is 40-80 mg (MR 2.3.1. 1915-04. "Recommended levels of consumption of food and biologically active substances." - M., 2004. 36 p.).

The addition of betulin to the fat of Iwashi sardine at a mass ratio of the ingredients fat: betulin - 100: 0.02-0.10, ensured the storage of fat while maintaining normal oxidative deterioration (acid and peroxide number) at a temperature not higher than 25 ° C: a) for the filling form - 15-20 months, b) for fat encapsulated in soft gelatin capsules - 38 months.

A decrease in the addition of betulin to less than 0.02% to the fat mass is reflected in the duration of its storage, it is significantly reduced. An increase in the content of betulin in dietary supplements of more than 0.1% does not increase the shelf life of the dietary supplement, but leads to the fact that betulin precipitates, thus losing its consumer appeal.

To obtain the claimed dietary supplement, fat is preliminarily obtained from sardine by one of the known methods (RF Patent No. 2114163, IPC C11B 1/12, publ. 27.06.1998). The separation of fat from the raw material of cut fish (ivashi sardines) is carried out using a super decanter (highly efficient separator), heating the minced meat minced on a top (industrial meat grinder) to a temperature of 85-90 ° C. Separation of the mass into fat, cake (solid residue) and glue water on a superdecanter is carried out at a temperature of 75-85 ° C. The duration of the process of obtaining fat at industrial loading does not exceed 2 hours, which reduces the accumulation of lipid peroxidation products. The fat is washed with water heated to 50 ° C 3 times to remove the bulk of the emulsified protein. Drying of fat is carried out in a reactor at a temperature of 50 ° C, the rotation of the stirrer is 60 rpm, the residual vacuum is 0.1-0.15 kg / cm ² and the duration of the process is 1 hour, the fat is filtered through belting. If the acid number is exceeded (more than 4.0 mg KOH / g fat), refining is carried out at a temperature of 50 ° C in the presence of a 10% solution of potassium or sodium alkali, followed by washing the fat with water (3 times). Further, to remove the unpleasant fishy odor, deodorize the fat. Mechanical impurities and coagulated protein are finally removed from the fat by filtration through belting or other dense tissue. The obtained fat from Iwashi sardine is a rich source of PUFAs of the omega-3 family, marine phospholipids and allows you to meet the daily requirement of the human body for them when consuming 3.6 ml (3.3 g) of fat.

The task is solved in the following way.

The natural antioxidant betulin in an amount of 0.02-0.10% is added to the fat heated to a temperature of 38-40 ° C, mixed thoroughly for at least 5 minutes, sent for encapsulation or filling into a container made of molten glass or dark glass.

The content of phospholipids in the prepared fat is 5.5% of the mass, of which 57.0% is represented by phosphatidylcholine (PC), 27.0% - phosphatidylethanolamine (PE), 3.8% - phosphatidylinositol, 2.8% - phosphatidylserine, 5 , 5% - sphingomyelin, the rest of the lyso-forms of PC and PE. The characteristics of the fatty acid composition in fat from Iwashi sardine are shown in Table 1.

The stated technical problem is also solved by the method of applying dietary supplements to food to normalize lipid metabolism.

A method of using a biologically active food supplement to normalize lipid metabolism, which consists in taking by patients the dietary supplement according to claim 1 in an amount of 3.6 ml per day for at least 21 days.

Biologically active food supplement for lipid metabolism correction contains 341 mg of polyunsaturated fatty acids in 1 ml of fat mixture, including the omega-3 family - 281.5 mg, the sum of eicosapentaenoic and docosahexaenoic acids is 221.5 mg, and the phospholipid content is 50 mg ...

The health-improving effect of its consumption by the claimed dietary supplement is manifested due to the effect of polyunsaturated fatty acids of the omega-3 series, primarily eicosapentaenoic and docosahexaenoic, on the lipid metabolism pathway in the human body. These acids are the ancestors of many highly active mediators. So, eicosapentanoic acid, a competitive inhibitor of arachidonic acid in its cascade, and the resulting prostaglandins of the 3rd series and leukotrienes of the 5th series are less vasoactive than from arachidonic acid - they do not cause vasoconstriction, thrombosis, and inflammatory reactions. Thus, there is a normalization of the activity of the cardiovascular system. Docosahexaenoic acid is a potent irreversible inhibitor of cyclooxygenase, an enzyme involved in the synthesis of prostanoids that relieves symptoms of inflammation and pain. In addition, this acid, along with eicosapentaenoic acid, is the initial substrate for the production of resolvins, maresins and neuroprotectins, which have a protective effect on the cells and tissues of the body and effectively reduce inflammatory processes. In fact, omega-3 PUFAs shift the balance in the body in general and in the cardiovascular system in particular, towards the normalization of lipid metabolism by affecting the pathways of lipid metabolism.

Phospholipids play a special role in the claimed dietary supplement. They, possessing excellent emulsifying properties, contribute to the rapid absorption of dietary supplements in the small intestine, which increases the digestibility of the product and the effectiveness of its effect on the body.

Consumption of a fat mixture in the amount of 3.6 ml once a day completely covers the human needs for PUFA and phospholipids.

It has been experimentally established that when the claimed supplement is consumed within 21 days, lipid metabolism is normalized (see Table 2).

The invention is illustrated by the following examples.

Example 1. Fat of Iwashi sardine in an amount of 100.0 kg is poured into a reactor with a jacket, heated to 40 ° C, a food additive "Betulin" is added in an amount of 0.1 kg, mixed thoroughly for 5 minutes, poured into glass bottles with a capacity of 100 cm ³ . 1 ml of fat (or 0.92 g) contains 341.0 mg of PUFA, including 281.5 mg of omega-3 fatty acids. The sum of EPA and DHA is 221.5 mg. The acid number is 0.9 mg KOH / g of fat, the peroxide number is 2.0 mmol of active oxygen / kg. Shelf life at a temperature not exceeding 25 ° C - 20 months. To provide the recommended daily dose of polyunsaturated fatty acids of the omega-3 family, an adult must take at least 3.6 ml (or 3.3 g) per day.

Example 2. The process is carried out as in example 1, except that the food additive "Betulin" is added in an amount of 0.02 kg. 1 ml of fat contains 341.0 mg of PUFA, including 281.5 mg of omega-3 fatty acids. The sum of EPA and DHA is 221.5 mg. The acid number is 0.9 mg KOH / g fat, the peroxide number is 2.4 mmol of active oxygen / kg. Shelf life at a temperature not exceeding 25 ° C - 15 months. To provide the recommended daily dose of polyunsaturated fatty acids of the omega-3 family, an adult must take at least 3.6 ml (3.3 g) per day.

Example 3. The process of obtaining the product is carried out as in example 2. The finished fat is sent to encapsulation to obtain soft gelatin capsules with a capacity of 0.5 cm ³ . One capsule contains 170.5 mg of PUFA, including 140.8 mg of omega-3 fatty acids. The sum of EPA and DHA is 110.8 mg. The acid number is 0.9 mg KOH / g of fat, the peroxide number is 2.0 mmol of active oxygen / kg. Shelf life at a temperature not exceeding 25 ° C - 38 months. To provide the recommended daily dose of polyunsaturated fatty acids of the omega-3 family, an adult needs to take 7 capsules per day.

Example 4. The process of obtaining the product is carried out as in example 2, except that the food additive "Betulin" is added to the fat in an amount of 0.05 kg, and the finished product is encapsulated in soft gelatin capsules with a capacity of 0.3 cm ³ . One capsule contains 102.3 mg of PUFA, including 84.5 mg of omega-3 fatty acids. The sum of EPA and DHA is 66.4 mg. The acid number is 0.9 mg KOH / g of fat, the peroxide number is 2.0 mmol of active oxygen / kg. Shelf life at a temperature not exceeding 25 ° C - 38 months. To provide the recommended daily dose of polyunsaturated fatty acids of the omega-3 family, an adult needs to take 12 capsules per day.

Example 5. Biologically active food supplement for the correction of lipid metabolism, obtained from the fat of Iwashi sardine with the stabilizer "Betulin", as in example 3, to determine its effectiveness was introduced into the diet of volunteers with impaired lipid metabolism (dyslipdemia) aged 50 to 70 years old, diagnosed on an outpatient basis. The experiment was approved by the Ethics Committee of the National Scientific Center for Marine Biology named after V.I. A.V. Zhirmunsky "of the Far Eastern Branch of the Russian Academy of Sciences (NSCMB FEB RAS). According to the Methodological Guidelines ("The procedure for conducting research on the effectiveness of specialized dietary medical and dietary preventive food products", 2016), the group for testing consisted of 15 people. to receive dietary supplements and further. There were no negative manifestations in patients taking dietary supplements obtained according to example 3 for more than 21 days. The daily allowance was 12 capsules of 0.3 ml. The volunteers did not take lipid-lowering drugs. To assess the effect of a diet enriched with omega-3 family PUFAs in the study participants before and after taking dietary supplements, a study of the blood lipid spectrum was carried out, namely, the blood plasma level of total cholesterol (TC), high-density lipoprotein cholesterol (HDL) was assessed , low density lipoprotein cholesterol (LDL), very low density lipoprotein cholesterol (VLDL), triglycerides (TG), the atherogenic coefficient (CA) was calculated, and the level of liver enzymes - alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was studied. Table 2 shows the results of the effectiveness of taking a biologically active food supplement to correct lipid metabolism.

Volunteers, after receiving a daily intake of dietary supplements as part of a diet that satisfies the daily requirement of the human body for polyunsaturated fatty acids of the omega-3 family, showed a tendency to correct lipid metabolism. It was found that against the background of a decrease in the level of total cholesterol, there is a significant decrease in LDL and CA cholesterol, as well as an increase in HDL cholesterol, the significance of differences in these values was 95% (t ˃2). This indicates a reduced risk of developing atherosclerosis. The results obtained revealed an obvious beneficial effect of the inclusion in the diet of patients with impaired lipid metabolism of dietary supplements with an increased content of PUFAs of the omega-3 family.

Dietary supplement for food to normalize lipid metabolism and method of its use

Table 1

Fatty acid Content % of the total fatty acids mg / g fat mg / ml fat Saturated 28.6 267.8 246.4 Monounsaturated 31.9 299.3 275.4 PUFA 39.5 370.7 341.0 Σ n-6 2.2 207.1 190.5 Σ n-3 32.2 306.0 281.5 20: 5n-3 (EPA) 18.8 179.0 164.7 22: 6n-3 (DHQ) 6.5 61.8 56.9 Σ EPA and DHA 25.3 240.8 221.5 Phospholipid content 5.5%
from fat mass 55.0 50.6

Claims (2)

1. Biologically active food supplement to normalize lipid metabolism, containing fish oil and a natural antioxidant, characterized in that it contains Iwashi sardine oil as fish oil, and betulin as a natural antioxidant, a food ingredient obtained from birch bark extract, when the following mass ratio of ingredients: 100: 0.02-0.10. 2. A method of using a biologically active food supplement to normalize lipid metabolism, which consists in taking by patients a biologically active supplement, including sardine fat and betulin with a mass ratio of ingredients 100: 0.02-0.10 in an amount of at least 3.6 ml per day for at least 21 days.

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